MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 ARTIFICIAL URINARY SPHINCTER; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400164
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Codes	Micturition Urgency (1871); Urinary Incontinence (4572)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced urinary tract symptoms including urgency, which progressed to total urinary incontinence.A pelvic x-ray was performed and revealed a fluid loss within the system; therefore, the aus was removed and replaced.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for balloon is (b)(4).Upon receipt at our quality assurance laboratory, this artificial urinary sphincter (aus) underwent a thorough analysis.The cuff was visually inspected and tested for leaks.Visual examination revealed that the cuff shell was identified to have folds and scaling on the backing.No leaks were found.The balloon was visually inspected, leak and functionally tested.Visual inspection revealed that the balloon had had scaling on the adaptor junction and tubing was worn to the filament.No leaks were found in the balloon, and the balloon passed the functional test.The pump was visually inspected, leak and functionally tested.Visual inspection revealed that the pump was worn down the filament and a tubing hole from fatigue was identified.The pump tubing had a fluid loss from fatigue.The pump passed the functional test.Based on the available test results and investigation, the reported allegation of device fluid leak is unable to be confirmed.There was no allegation against the pump; however, the pump tubing not passing the leakage test could be the cause of the reported device fluid leak and could affect the product performance.Additionally, the patient symptoms of urinary incontinence and urinary urgency were confirmed as a known inherent risk.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this artificial urinary sphincter (aus) experienced urinary tract symptoms including urgency, which progressed to total urinary incontinence.A pelvic x-ray was performed and revealed a fluid loss within the system; therefore, the aus was removed and replaced.No additional patient complications were reported.

• Brand Name: AMS 800 ARTIFICIAL URINARY SPHINCTER
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23297265
• Report Number: 2124215-2025-72416
• Device Sequence Number: 9917484
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: (01)00878953000756(17)200914(10)103712010
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/14/2020
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 103712010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: UPN: 72400024 / LOT: 108722013.; BALLOON: UPN: 72400024 / LOT: 108722013.; PUMP: UPN: 72400098 / LOT: 839822009.; PUMP: UPN: 72400098 / LOT: 839822009.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown